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A critical step in bringing a medical device to market is demonstrating the safety and effectiveness of the product. This webinar is meant to introduce participants to the role clinical trials play in the development of a medical device and to provide an overview of the process involved in carrying out a clinical trial within a framework of good clinical practices (GCP) and regulatory requirements. The focus will be on clinical trials for device approval in Canada, United States, and Europe.

Presenter: Alvira Macanovic – CIMTEC, IP, Regulatory and Clinical Affairs Manager

Dr. Alvira Macanovic obtained a Bachelor of Science in Biochemistry from McGill University and a PhD in Chemistry in the field of diagnostics from Concordia University.

She started her career as a research scientist in the immunochemistry department of a multi-national contract research organization (CRO) managing studies for domestic and international clients. In that role, she gained practical knowledge of GxPs (GCPs, GLPs, GMPs), as well as regulatory guidelines, policies, standards and practices and requirements.

Prior to joining CIMTEC, Alvira worked as a scientific consultant for two Toronto law firms where she applied her regulatory knowledge to advise clients on regulatory requirements and in developing strategies for bringing products to market in regulated industries, including, medical devices, in vitro diagnostics, pharmaceuticals, biologics and biotechnology, natural health products and functional foods.

Alvira applies her vast knowledge of the product development pathway in the medical imaging and device sector in managing CIMTEC’s clinical testing services and providing consultative services to help clients develop and bring medical imaging devices to the commercial market.